Shots:
- Foresee Pharmaceuticals reported its P-III (Casppian) Study data of FP-001 (leuprolide mesylate 42mg; administered every six months), a sustained-release GnRH agonist, met its 1EP in children with central precocious puberty (CPP)
- The study showed that 94% of pts achieved serum LH suppression to <4 mIU/mL at 60 mins. following a GnRHa stimulation test at Wk. 24, exceeding the pre-specified success criterion (≥80%) and achieving statistical significance (P=0.0005)
- FP-001 was well tolerated, with a consistent safety profile; Foresee plans to engage with global regulators to discuss NDA submission by mid-2026
Ref: Foresee Pharmaceuticals | Image: Foresee Pharmaceuticals | Press Release
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